REDUCE Post Approval Study - GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO)
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Description
This study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
Details
Adult
Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment. Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver... Patient is able to tolerate antiplatelet therapy
MoreLocations
Harmony Campus
Medical Center of the Rockies
Principal Investigator
![Photograph of Justin Strote](https://researchstudies.cuanschutz.edu/Content/images/investigators/no-photo.jpg)
Justin Strote
Study ID
Protocol Number: 19-6030
More information available at ClinicalTrials.gov: NCT03821129
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